1. Field
This application relates generally to medical devices, particularly to a prosthesis constructed to duplicate the posterior vaginal wall.
2. Prior Art
After an episiotomy, vaginoplasty or vaginal tear, the remaining healed scar on the posterior vaginal wall can be painful or the area on the posterior vaginal wall can be hypersensitive. There is a need for a sensitive area covering device that can be worn on the posterior vaginal wall during coitus to reduce the friction on this area to help with the hypersensitivity in this area. Standard medical practice when performing an episiotomy is to cut from the introitus towards and into the perineum. These areas are the site of various surgical and non-surgical traumas comprising tears, occlusions, sutures, scars, sores, genital warts and genital herpes all of which can cause the posterior vaginal wall, the introitus and the perineal area to be hypersensitive.
In addition, a woman's vagina and vaginal entrance naturally differ in size from person to person. Factors such as aging, overstretching from childbirth or sexual activities can further cause the vagina and vaginal entrance to lose elasticity. To help tighten her vagina, a woman has a few options available to choose from. These options have varying degrees of success and risk.
Since early times, some women have used creams that claim to tighten the vagina. Evidence shows that noticeable tightening effects of these ointments are considered to be ineffective. Application of the cream to the interior walls of the vagina is difficult, embarrassing, and must be properly timed to correspond with sexual intercourse. Some of the creams contain benzocaine, alum or petroleum jelly, none of which are recommended for being inserted into the vagina.
Another prior art alternative is to perform an alum douche. Alum douches are not recommended by doctors, can be irritating and are associated with increased risk of pelvic and vaginal infections. Alum is an astringent that acts to contract the vagina walls, but there is no way to judge how long the constriction will last nor a way to control the extent of tightening.
Performing exercises designed to strengthen pubococcygeal muscles, such as the exercises developed by Dr. Arnold Kegel of the University of California, is a doctor recommended way to exercise the vaginal muscles to tighten the vagina. For those who find it difficult to identify these muscles, biofeedback systems can be useful. These muscles can also be exercised using various vaginal exercise devices (U.S. Pat. No. 4,241,912 to Mercer et al. (1980), U.S. Pat. No. 4,048,985 to Sasse (1977), U.S. Pat. No. 4,895,363 to Plevnik et al. (1990), U.S. Pat. No. 5,256,123 to Reinbolt (1993), to name a few). One disadvantage to these exercise methods is that it takes a long time, an average of 6 to 12 weeks, to see results, so one must be dedicated to maintain the muscle development program long enough for it to be of benefit. In addition, like any muscle, if the muscles are not continually worked, the pubococcygeal muscles will lose their strength. Another disadvantage is that to be of benefit during sexual intercourse, the female must consciously flex her interior muscles, thus taking away from her ability to relax and enjoy the act of intercourse itself.
Electrotherapy of the vagina such as described in U.S. Pat. No. 3,640,284 to De Langis (1972), reproduces the physical and chemical phenomenon connected with normal muscular work. A small electronic probe is placed in the vagina and painless, low frequency electrical currents cause contractions of the vaginal muscles. Alternatively, the vaginal muscles can be exercised with attractive magnets such as described in U.S. Pat. No. 6,672,996 to Ross et al. (2004). Unfortunately, both of these methods are expensive and not viable for use in home conditions.
Vaginoplasty is a surgical procedure that helps tighten the vaginal muscles as well as the supporting tissues of the vaginal wall. Any excess vaginal mucosal tissue is excised or removed with a laser. The result is an immediate decrease in the size of vaginal muscles. This is a costly procedure, and has the following risks: problems with anesthesia, bleeding, hematoma, infection with swelling, soreness and tenderness and post operative scarring. There is also the risk of losing sensitivity due to complications within the vaginal wall area and muscles.
U.S. Publication No. 2009/0281373, by Mark, describes a sexual aid device which is inserted within a human female's vagina to provide a sensation of increased fullness to the female and a sensation of increased tightness and friction to a penis of a human male during sexual intercourse.
Deficiencies in Mark's sexual aid device and method are as follows:                (a) Mark's device is not engineered or designed for shielding the posterior vaginal wall, the introitus or the perineum while in use (use here comprises sitting, walking, normal daily activities and coitus). Mark's device neglects to cover a broad area comprising the posterior vaginal wall, the introitus and the perineum, thus exposing women, who experience hypersensitivity, to frictional contact in these areas. The posterior vaginal wall, the introitus and the perineum are often the location of hypersensitivity, including but not limited to, tears, occlusions, sutures, scars, sores, warts and herpes. Furthermore, Mark's device guarantees frictional contact along the full extent of the posterior vaginal wall, the introitus and the perineum when the device is attached to a penis via a ring or a condom. This frictional contact further irritates hypersensitive areas.        (b) Mark's device is not engineered or designed to be used outside of coitus. His device is not designed to be retained exclusively by the vagina at all times. Within the vagina, Mark's device is designed with only one mechanism of retention, a bulbous head. When a female uses Mark's device, and is in a standing position, the device is susceptible to movement by gravity such that the bulbous head drops towards the vaginal entrance. Mark's embodiment that has an anal penetrator serves as a second means of retention, however, this form of retention complicates daily restroom activities and may otherwise not be suitable for all day wear. Mark's device is not designed to be comfortably worn all day and all night.        (c) Mark's device does not have shape geometry that allows the device to seat itself when being inserted into the vagina and to remain seated during use without penetrating the anus. When Mark's device is positioned in a single orifice, his device is not self-locating, is not self-retaining, does not remain in a user defined position and does not resist rotation. Mark's device does not have a mechanism to unfurl which serves to pull the device into the vagina when it passes the vaginal entrance muscles nor does his device have shape and geometry to prevent the device from wholly entering the vagina while being inserted and while in use. Mark's device does not have features which retain the device in a user-defined, predetermined position inside and outside of the vagina.        (d) Mark's device is not engineered or designed to be exclusively retained by the vagina to enable a female to use a blood collection device, such as a tampon. Furthermore, his device does not function to support a method of transdermal medication delivery.        (e) Mark's device is not designed to accommodate insertable and removable electronic devices. His device has built-in electronic devices which increase the manufacturing costs, limit the end users' options, and render Mark's device not easily recyclable.        (f) Mark's embodiments that are manufactured from a single material stretch the introitus muscles when the device is inserted. To minimize stretching of the introitus muscles, Mark does have an embodiment that is cylindrically collapsible for insertion into the vagina, however, this embodiment requires at least two different types of materials and a more complex manufacturing process which complicates recycling of the device. Mark's device does not take advantage of an engineered shape that is simple to manufacture and that can be rolled by hand into a narrow cylinder for easy insertion into the vagina without stretching the introitus muscles.        
Therefore, there is a need for some women for a non-surgical, cost-effective solution to shield at all times a sensitive area on the posterior vaginal wall, the introitus and the perineal area, to restore the sensation of a tightened vaginal entrance and to enable women with larger vaginas to use a tampon. In this regard, the posterior vaginal wall prosthesis substantially fulfills this need. The posterior vaginal wall prosthesis according to the present invention substantially departs from the conventional concepts and designs of any prior art.